FDA issues draft guidance on opioid-use disorder devices

The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.

The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.

For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”

Related: Could minimally invasive neuromod tackle the opioid epidemic?

The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, o…

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Teva and Allergan reportedly agree to pay $5B billion to settle opioid allegations

[Prescription pill bottle image courtesy of Pexels]

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and AbbVie unit Allergan Plc (NYSE:ABBV) could pay more than $5 billion in total to settle some 3,500 opioid lawsuits, according to Bloomberg. While the two companies are willing to settle the suits in the consolidated case, the deal has not been finalized.

The consolidated case is titled In Re National Prescription Opioid Litigation, 17-MD-2804, U.S. District Court, Northern District of Ohio (Cleveland).

Teva and Allergan have reportedly been in mediation for more than a year.

In 2016, Teva completed a $40.5 billion acquisition of Allergan’s generic business, including generic opioids.

In 2020, AbbVie acquired Allergan.

Earlier this year, Teva Pharmaceuticals and AbbVie reached a deal with Rhode Island for a total of $28.5 million to settle opioid-related claims.

Teva entered…

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Johnson & Johnson and drug distributors agree to pay $590M in opioid settlement agreement with U.S. tribes

Johnson & Johnson (NYSE:JNJ) and its U.S. subsidiary Janssen Pharmaceutical Companies have reached a $150 million settlement agreement with federally-recognized tribes related to opioid-related claims payable over two years.

The case was filed in the U.S. District Court, Northern District of Ohio, Eastern Division.

The settlement notes that American Indians have one of the highest rates of opioid overdoses per capita in the U.S. Tribal governments have thus been forced to pay considerable sums to “cover the costs of the opioid crisis, including increased costs for health care, social services, child welfare, law enforcement and other government services that Tribes provide to their citizens,” it added.

McKesson (NYSE:MCK), AmerisourceBergen (NYSE:ABC) and Cardinal Health (NYSE:CAH) have reached similar agreements with U.S. tribes.

In all, the companies will pay at least $590 million to settle lawsuits related to opioid medications.

The …

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Johnson & Johnson reaches opioid settlement with Colorado and Nevada

Johnson & Johnson (NYSE:JNJ) has reached a settlement agreement with Colorado and Nevada to put opioid-related allegations there to bed. 

Colorado will receive $385 million from Johnson & Johnson and the drug distributors McKesson (NYSE:MCK), AmerisourceBergen (NYSE: ABC) and Cardinal Health (NYSE:CAH).

Nevada will receive nearly $285.2 million as part of the overall settlement, which is earmarked for battling the ongoing opioid epidemic, according to Nevada Attorney General Aaron D. Ford. Of that sum, Johnson & Johnson will pay $63 million, according to a press release.

“The funds that our state will receive going forward will help us save lives and mitigate the harms done to our residents because of the ongoing opioid epidemic,” Ford said in a statement. “Our team has worked diligently to get Nevada the resources we must have to help Nevadans in need in one of the epidemic’s hardest-hit states, and to obtain justice from many opioid manufac…

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Why Tryp Therapeutics is exploring the use of psilocybin to treat chronic pain

Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder.

But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego).

The company is exploring the use of psilocybin-based drugs for treating eating disorders and chronic pain.

“There’s a lot of similarities mechanistically in terms of how psilocybin works to treat depression that we think could apply to treating pain,” McKee said.

Tryp is working with researchers who believe psilocybin can support neuroplasticity in a manner that reduces chronic pain. Tryp’s research partners believe psilocybin can help correct abnormal neural firing in patients with chronic pain and related conditions.

Greg McKee

If psilocybin promotes neuroplasticity in huma…

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J&J’s proposed opioid settlement framework eclipses its $2B talc penalty

The Supreme Court’s decision to deny reviewing a Johnson & Johnson talc lawsuit leaves the company on the hook for paying $2.5 billion, or $2.1 billion in damages plus interest.

But the talc litigation development also serves as a reminder that the company faces multiple litigation risks — some related to opioid litigation. The company has a proposed opioid settlement framework recommending a $5 billion payment to settle outstanding litigation. “If finalized, this would considerably reduce uncertainty related to J&J’s opioid exposures,” concluded a recent Moody’s report.

The company had initially agreed to a $4 billion settlement framework in negotiations with state attorneys general. Last October, the company agreed to pay an additional $1 billion as part of that framework.

The Supreme Court’s denial of a talc verdict appeal will leave Moody’s Aaa rating for J&J unchanged. “The company’s financial flexibility remains very strong, with gross …

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Purdue Pharma boost settlement offer to $4.28 billion

Purdue Pharma has proposed paying an additional approximately $500 million in cash to settle hundreds of thousands of opioid lawsuits.

As part of a proposed bankruptcy settlement, the payments would be spaced out over the next decade. The Sackler family that owns the company has earlier agreed to pay an additional $4.2 billion to settle a range of civil claims. The total settlement amount is roughly $4.28 billion.

The latest proposal has immediately faced opposition from two dozen state attorneys general.

The proposal, which would also strip the Sackler family of ownership of Purdue Pharma, would need approval from a federal bankruptcy court in White Plains, N.Y.

But the agreement would allow the family to continue managing offshore subsidiaries for at least seven years.

Purdue family admitted in 2007 and 2020 that it illegally marked opioids such as OxyContin in plea deals with the Justice Department.

The latest proposal would turn …

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McKinsey to pay $573M in opioid settlement

The prestigious consulting firm McKinsey has struck a deal with 47 states over its role in the opioid crisis. 

Notably, the company had advised OxyContin manufacturer Purdue Pharma (Stamford, Conn.) on “turbocharging” opioid sales. The pharma company had worked with McKinsey for 15 years. 

The Justice Department concluded that McKinsey helped manage a Purdue Pharma sales program known as “Evolve to Excellence” that pushed medically questionable OxyContin prescriptions.

There is no admission of wrongdoing in the McKinsey settlement, but the firm will publicly share tens of thousands of pages of documents linked to its opioid work. 

“With this agreement, we hope to be part of the solution to the opioid crisis in the U.S.,” said Kevin Sneader, global managing partner of McKinsey, in prepared remarks. 

Sneader also apologized for the firm’s role in the opioid crisis while also maintaining that the firm’s past work with opioid makers was lawful.…

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